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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX REFLUX MANAGEMENT SYSTEM; ANTI-REFLUX IMPLANT
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TORAX MEDICAL, INC. LINX REFLUX MANAGEMENT SYSTEM; ANTI-REFLUX IMPLANT Back to Search Results
Model Number LS15
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Dysphagia/ Odynophagia (1815); Heartburn/Indigestion (1883)
Date of Event 10/27/2017
Type of Reportable Event Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced mild dysphagia and ongoing gerd symptoms leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure including linx device implantation occurred without issue on (b)(6) 2012.-device explant due to mild dysphagia and ongoing gerd occurred on (b)(6) 2017; a fundoplication was performed at the time of explant.-device was found in the correct position/geometry.
 
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Brand Name
LINX REFLUX MANAGEMENT SYSTEM
Common Device Name
ANTI-REFLUX IMPLANT
Manufacturer (Section D)
TORAX MEDICAL, INC.
4188 lexington avenue n
shoreview MN 55126
MDR Report Key7228627
Report Number3008766073-2018-00015
Device Sequence Number19122222
Product Code LEI
UDI-Device Identifier00855106005042
UDI-Public00855106005042
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P100049
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Physician
Device Expiration Date04/10/2016
Device Model NumberLS15
Device Lot Number3442
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/04/2018
Initial Report FDA Received Date01/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Disability;
Patient Age58 YR
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